Lindsay Cameron, Kouzouna Aphrodite, Simcox Christopher, Pandyan Anand D
Department of Physiotherapy, South Eastern Health and Social Care Trust, Upper Newtownards Road, Belfast, Co Down, Northern Ireland, UK, BT161RH.
Cochrane Database Syst Rev. 2016 Oct 6;10(10):CD010362. doi: 10.1002/14651858.CD010362.pub2.
The long-term risk of stroke increases with age, and stroke is a common cause of disability in the community. Spasticity is considered a significantly disabling impairment that develops in people who have had a stroke. The burden of care is higher in stroke survivors who have spasticity when compared with stroke survivors without spasticity with regard to treatment costs, quality of life, and caregiver burden.
To assess if pharmacological interventions for spasticity are more effective than no intervention, normal practice, or control at improving function following stroke.
We searched the Cochrane Stroke Group Trials Register (May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 5), MEDLINE (1946 to May 2016), Embase (2008 to May 2016), CINAHL (1982 to May 2016), AMED (1985 to May 2016), and eight further databases and trial registers. In an effort to identify further studies, we undertook handsearches of reference lists and contacted study authors and commercial companies.
We included randomised controlled trials (RCTs) that compared any systemically acting or locally acting drug versus placebo, control, or comparative drug with the aim of treating spasticity.
Two review authors independently assessed the studies for inclusion and extracted the data. We assessed the included studies for both quality and risk of bias. We contacted study authors to request further information when necessary.
We included seven RCTs with a total 403 participants. We found a high risk of bias in all but one RCT. Two of the seven RCTs assessed a systemic drug versus placebo. We pooled data on an indirect measure of spasticity (160 participants) from these two studies but found no significant effect (odds ratio (OR) 1.66, 95% confidence interval (CI) 0.21 to 13.07; I = 85%). We identified a significant risk of adverse events per participant occurring in the treatment group versus placebo group (risk ratio (RR) 1.65, 95% CI 1.12 to 2.42; 160 participants; I = 0%). Only one of these studies used a functional outcome measure, and we found no significant difference between groups.Of the other five studies, two assessed a systemic drug versus another systemic drug, one assessed a systemic drug versus local drug, and the final two assessed a local drug versus another local drug.
AUTHORS' CONCLUSIONS: The lack of high-quality RCTs limited our ability to make specific conclusions. Evidence is insufficient to determine if systemic antispasmodics are effective at improving function following stroke.
中风的长期风险随年龄增长而增加,中风是社区中导致残疾的常见原因。痉挛被认为是中风患者出现的一种严重致残性损伤。与没有痉挛的中风幸存者相比,有痉挛的中风幸存者在治疗费用、生活质量和照顾者负担方面的护理负担更高。
评估针对痉挛的药物干预在改善中风后功能方面是否比不干预、常规治疗或对照更有效。
我们检索了Cochrane中风组试验注册库(2016年5月)、Cochrane对照试验中心注册库(CENTRAL,2016年第5期)、MEDLINE(1946年至2016年5月)、Embase(2008年至2016年5月)、CINAHL(1982年至2016年5月)、AMED(1985年至2016年5月)以及另外八个数据库和试验注册库。为了识别更多研究,我们对参考文献列表进行了手工检索,并联系了研究作者和商业公司。
我们纳入了随机对照试验(RCT),这些试验比较了任何全身作用或局部作用的药物与安慰剂、对照或比较药物,目的是治疗痉挛。
两位综述作者独立评估研究是否纳入并提取数据。我们评估了纳入研究的质量和偏倚风险。必要时,我们联系研究作者以获取更多信息。
我们纳入了7项RCT,共403名参与者。我们发现除一项RCT外,其他所有研究都存在较高的偏倚风险。7项RCT中有2项评估了全身药物与安慰剂的比较。我们汇总了这两项研究中关于痉挛间接测量指标的数据(160名参与者),但未发现显著效果(优势比(OR)1.66,95%置信区间(CI)0.21至13.07;I² = 85%)。我们发现治疗组与安慰剂组相比,每位参与者发生不良事件的风险显著增加(风险比(RR)1.65,95%CI 1.12至2.42;160名参与者;I² = 0%)。这些研究中只有一项使用了功能结局指标,我们发现两组之间没有显著差异。在其他五项研究中,两项评估了全身药物与另一种全身药物的比较,一项评估了全身药物与局部药物的比较,最后两项评估了局部药物与另一种局部药物的比较。
缺乏高质量的RCT限制了我们得出具体结论的能力。证据不足,无法确定全身抗痉挛药物在改善中风后功能方面是否有效。